Fortvita Biologics · 1 month ago
Clinical Research Manager (CRM)
United States
Full-time
Remote
Senior Level, Lead/Staff
10+ years expFortvita Biologics is a biopharmaceutical company specializing in antibody discovery and engineering. They are seeking a Clinical Research Manager (CRM) to lead the planning, execution, and delivery of Phase 1-3 clinical trials, overseeing trial operations and ensuring compliance with regulatory standards.
Biotechnology
Responsibilities
Manage, mentor, and support a team of 8 CRAs; provide ongoing coaching, performance management, and professional development
Oversee the execution of the Phase 3 clinical study, ensuring adherence to protocol, timelines, GCP, FDA regulations, and company SOPs
Guide the CRA team in site selection, initiation, monitoring, and closeout visits to ensure high-quality data collection and compliance
Identify operational risks early and implement mitigation strategies to resolve site and study-level challenges
Ensure data integrity, patient safety, and regulatory compliance throughout the study lifecycle
Serve as the primary point of contact between CRAs, clinical project management, medical monitors, vendors, and investigational sites
Prepare and present study progress reports, metrics, and issue logs to upper management and cross-functional teams
Maintain documentation and processes to ensure the study is always inspection-ready
Qualification
Required
Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related field
Minimum of 10 years of clinical research experience, including at least 5 years in clinical trial management or team leadership roles
Strong working Knowledge of FDA and ICH-GCP regulatory requirements
Proven ability to manage a team of CRAs
Proficient in CTMS, eTMF, and EDC systems
Excellent communication, proven leadership, organizational, and interpersonal skills
Excellent written and verbal communication; ability to present complex information clearly
Willingness to travel as required (up to 40%)
Preferred
Oncology trial experience is highly preferred
Prior experience working in global studies or multiple site operations
Ability to motivate teams and foster collaboration
Detail-oriented with strong problem-solving skills
Experience working in a fast-paced or startup environment
Benefits
Competitive base salary, bonus, and equity for all employees.
401(k) retirement plan with employer matching contributions.
Comprehensive medical, dental, and vision insurance.
Generous paid time off policy, including company holidays and floating holidays.
Company
Fortvita Biologics
Fortvita Biologics is a San Francisco Bay Area–based biopharmaceutical company advancing next-generation biologics with the goal of addressing critical health needs.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase